Crucell Terug naar discussie overzicht

Crucell & Ark Therapeutics

1. [verwijderd] 9 maart 2010 16:35

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   quote:

   maxen schreef:

   twee in phase II (waaronder Trinam).
   
   [/quote]
   
   Volgens de ark website zit Trinam in phase 3 (ook fast track fda en orphan)
   
   [quote=maxen]
   
   Crucell zou het alleen om Trinam veilig te stellen kunnen overnemen, en de rest er gratis bij krijgen.
   

   It crossed my mind.
   
   maar eens kijken wie er verschijnen in: www.thetakeoverpanel.org.uk/disclosur...
   
   p.s. off-topic, het is weer eens heerlijk koersen kijken de laatste tijd. Was er ook echt wel aan toe eerlijk gezegd.
   
2. harvester 9 maart 2010 18:50

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   De prijs van ARK is weer iets acceptabeler geworden vandaag. 13.5>11.5
   
   Alleen lijkt het management van ark te zoeken naar een manier om toch verder te kunnen met cerepro.
   Crucell zou verre moeten blijven van onder eigen regie ontwikelen van kankermedicijnen. Dat is gewoon te riskant en te duur voor Crucell.
   
   Wellicht is Glaxo voor dat belangrijke onderdeel te interesseren.
   
   Crucell heeft op zich genoeg projecten al lopen en hoeft helemaal dus niets te doen richting ARK.
   
   

   quote:

   winx08 schreef:

   [quote=maxen]
   twee in phase II (waaronder Trinam).
   
   [/quote]
   
   Volgens de ark website zit Trinam in phase 3 (ook fast track fda en orphan)
   
   [quote=maxen]
   
   Crucell zou het alleen om Trinam veilig te stellen kunnen overnemen, en de rest er gratis bij krijgen.
   [/quote]
   
   It crossed my mind.
   
   maar eens kijken wie er verschijnen in: www.thetakeoverpanel.org.uk/disclosur...
   
   p.s. off-topic, het is weer eens heerlijk koersen kijken de laatste tijd. Was er ook echt wel aan toe eerlijk gezegd.
   
   

3. [verwijderd] 9 maart 2010 19:34

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   Er zijn maar weinig bedrijven die beter gepositioneerd zijn om waarde te Ark dan Crucell. Als Crucell management van mening kunnen zij goedkeuring op een van deze producten in de komende jaren krijgen de uitgaven minder dan een tiende van het oorlog op de borst bij een brand verkoop zou wel eens de moeite waard. Ik vertrouw het beheer van Crucell's in dit besluit.
   
   There are very few companies that are better positioned to value Ark than is Crucell. If Crucell management believes they can get approval on one of these products in the next few years, spending less than one tenth of it's war chest in a fire sale could be well worth it. I trust Crucell's management in this decision.
4. [verwijderd] 19 april 2010 08:52

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   First Peripheral Vascular Disease patient treated with high dose VEGF-D
   in Phase I/IIa trial
   
   Biobypass nieuw leven ingeblazen?
   
   London, UK, 19 April 2010 - Ark Therapeutics Group plc ("Ark" or the "Company") announces today that the first patient has been treated in the high dose Phase I/IIa trial of adenoviral Vascular Endothelial Growth Factor-D ("VEGF-D") in patients with peripheral vascular disease ("PVD"). The trial is being undertaken in collaboration with the AI Virtanen Institute in Kuopio, Finland. The programme (EG016) uses the angiogenic VEGF-D gene (Ad-VEGF-D) in Ark's already successfully developed adenovirus platform.
   
   
   
   The patient was given 1 X 1011viral particles of Ad-VEGF-D into lower leg muscles one day before femoropopliteal artery bypass surgery to restore the main arterial blood flow to the lower leg.
   
   
   
   An estimated 300,0001 patients per annum in the US and Europe, have sufficiently impaired blood flow to the lower limb due to atherosclerosis to require an operation to bypass the blocked blood vessel. Patients with impaired lower limb circulation suffer pain on using their legs (claudication) and in more severe cases, the leg tissue below the blocked artery dies and the leg has to be amputated.
   
   
   
   The bypass operation connects a length of healthy blood vessel (taken from elsewhere in the patient's body, or in some cases a synthetic vessel) between the femoral artery which has good blood flow in the upper leg and the popliteal artery further down the leg to bypass the blocked area. The extent to which this operation is successful relies both on the extent to which the main arterial flow to the lower leg is restored by the bypass operation and the extent to which the patient can re-grow small blood vessels (capillaries) within the leg tissues to carry new blood supply to the areas which have had insufficient blood (ischaemic) for a period of time. Adenoviral mediated VEGF has already been shown by researchers in Finland to significantly increase new capillary growth in the ischaemic leg (AdVEGF-A, n = 54 patients, p<0.03)2
   
   
   
   The Phase I/IIa trial is a controlled study in patients with peripheral vascular disease who require femoropopliteal bypass surgery. Initially this programme will compare different doses of VEGF D longform prior to moving to VEGF D∆N∆C (shortform VEGF-D). Patients will receive either 1x109, 1x1011 viral particles of Ad-VEGF-D, administered by multiple injection into the muscle downstream of the bypass site 1-2 days before the bypass operation, allowing time for the gene to start to work prior to the bypass operation. This pre-bypass treatment approach should allow some advance restoration of the peripheral circulation improving the success of the bypass operation.
   
   
   
   The study has been approved by the Finnish National Agency for Medicines (NAM) and is being conducted by Professor Ylä-Herttuala of the AI Virtanen Institute in Kuopio and Dr. Kimmo Mäkinen and Dr. Ismo Vajanto of the Kuopio University Hospital. The study will assess the safety of EG016 as well as providing initial efficacy data.
   
   
   
   Prof John Martin Chief Scientific Officer at Ark, commented: "Having already demonstrated success in PVD patients in an earlier study with VEGF-A, we are very optimistic about the success of this trial and we believe our decisions to use VEGF-D and provide EG016 treatment prior to the bypass operation will enhance the overall benefits and success of both treatments to patients."
   
   
   
   Dr Nigel Parker Chief Executive Officer of Ark added: "This enrolment is an important milestone. The progress we continue to make at Ark is facilitated by the use of our established adenoviral platform and a successful co-operation between academia and industry. EG016 is a very exciting product opportunity in a large market with significant unmet clinical need and we look forward to announcing further trial progress as well as news on our other VEGF-D clinical candidates as the year progresses. Our angiogenic gene-based portfolio continues to grow in strength."
   
   
   
   Refs.
   
   1 Company estimates and various sources
   
   2 Increased Vascularity Detected by Digital Subtraction Angiography after VEGF Gene Transfer to Human Lower Limb Artery: A Randomized, Placebo-Controlled, Double-Blinded Phase II Study. Kimmo Mäkinen, Hannu Manninen,Marja Hedman,Pekka Matsi,Hanna Mussalo,Esko Alhava and Seppo Ylä-Herttuala. Mol Ther 2002:6:127-133
   
   
   
   -Ends-
   
   
   
   
5. flosz 19 april 2010 10:07

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   tinyurl.com/y68fobu
   ************
   
   GenVec BIOBYPASS® (AdGVVEGF121)
   This study has been terminated.
   
   clinicaltrials.gov/show/NCT00215696
   www.genvec.com/download/BIOBYPASS_Ph2...
   www.genvec.com/download/ACCPrf6_FINAL...
   
   BIOBYPASS® is intended to induce new blood vessel formation (angiogenesis) in tissues with inadequate blood flow. Vascular endothelial growth factor (VEGF) is a natural protein needed for the body's normal process of growing new blood vessels. BIOBYPASS® delivers GenVec's proprietary VEGF121 gene to the heart so that new blood vessels are formed in the diseased ischemic tissue. The VEGF gene is carried to the site of disease by GenVec's proprietary adenovector.
   www.iex.nl/forum/topic.asp?forum=228&...
   **************
   EG016(Ad-VEGF-D)
   During the period, progress towards first human trials was made with
   two further gene medicine programmes both based on our adenoviral
   technology and the VEGF-D genes secured through our acquisition of
   Lymphatix Oy in 2008. EG016, for peripheral vascular disease, moved
   into the later stages of regulatory clearance in collaboration with the
   AI Virtanen Institute in Finland and enrolment of its first patient is
   expected in early 2010. We will commence treatment with longform
   VEGF-D as used in Trinam® and then use shortform D to compare
   the two genes which have marginally different receptor binding
   properties and hence different effects on the blood and lymphatic
   vasculature.
   
   Clinical stage I/IIa EG016 (Peripheral Vascular Disease)
   A significant problem for patients with
   peripheral vascular disease is that despite
   bypass surgery to overcome blockage of the
   main blood vessel to the lower leg, they still
   have troublesome symptoms. This is because
   there is inadequate blood penetrating from
   the large vessels into the smaller vessels that
   deliver oxygenated blood to the muscles of
   the leg (so-called “poor run-off”).
   Using Ark’s established adenoviral platform,
   we can deliver angiogenic genes (VEGF-D) to
   promote the growth of these smaller vessels
   around the time of the main surgery. These
   new vessels will improve the supply of
   oxygen to the muscles and A Phase I/IIa study in collaboration with the
   AI Virtanen Institute in Finland started and first
   patients treated. Comparisons to be made
   between VEGF-D long and short form. No
   evident adverse consequences of the
   treatment have been reported.
   
   VEGF-D IN PERIPHERAL VASCULAR DISEASE (EG016)
   2009
   > Clinical assessment of longform VEGF-D
   Looking ahead – 2010
   > Commence clinical studies with optimal VEGF-D (shortform)
   investors.arktherapeutics.com/pdf/Ann...
   
6. [verwijderd] 5 mei 2010 11:48

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   Ark will seek a partner to complete the clinical development for Cerepro® now that all other aspects including the adenoviral platform are cleared for approval and will also minimise expenditure on Trinam® by modifying the existing trial to a Phase IIb and then seeking a partner for a final Phase III trial. Ark believes that the regulatory achievement with the adenoviral platform will also enable the Company to validate its early stage programmes more rapidly through partnering deals.
   
   Trinam® - As part of the emphasis on extending the cash runway and seeking early proceeds from partnering,the Company has decided to amend the current Phase III trial to a Phase IIb. The results from this trial are expected to be available in mid 2011, at which point Ark intends to seek a partner in order to complete the Phase III development. The Company is giving full attention to increasing the rate of recruitment into the current study, which has been impacted by the previously reported third party manufacturing issue and the management focus on the Cerepro® MAA.
   
   RNS Number : 3485L
   Ark Therapeutics Group PLC
   05 May 2010
   
7. [verwijderd] 5 mei 2010 11:54

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   quote:

   winx08 schreef:

   Trinam® - As part of the emphasis on extending the cash runway and seeking early proceeds from partnering,the Company has decided to amend the current Phase III trial to a Phase IIb. The results from this trial are expected to be available in mid 2011, at which point Ark intends to seek a partner in order to complete the Phase III development. The Company is giving full attention to increasing the rate of recruitment into the current study, which has been impacted by the previously reported third party manufacturing issue and the management focus on the Cerepro® MAA.
   
   RNS Number : 3485L
   Ark Therapeutics Group PLC
   05 May 2010
   
   

   Opnieuw (flinke) uitstel.
   Trinam zou 2 jaar geleden al goedgekeurd worden (volgens Brus).
   
   Het blijft maar doorgaan.
   
   Dirk
8. [verwijderd] 5 mei 2010 12:12

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   Over 5 jaar bij optellen , Dirk.
   
   Het Crucell sprookje = uit geblazen door ... met een grote fluit.
9. flosz 5 mei 2010 12:21

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   quote:

   Dirk R. Wijnen schreef:

   Opnieuw (flinke) uitstel.
   Trinam zou 2 jaar geleden al goedgekeurd worden (volgens Brus).
   Het blijft maar doorgaan.
   Dirk
   

   9 maart(eigenlijk al eerder) was het gebrek aan pecunia bij Ark zeer duidelijk en daar is Brus verantwoordelijk voor......DUH.
   Dit heeft NIETS met "foutjes" van Crucell te maken.
   Vanuit Crucell is enkel de verwachting van Ark openbaar gemaakt.(Zoals (let op sammie)bv ook eerder de verwachting vanuit Sanofi is uitgesproken).
   
   (Uitspraak Kruimer Trinam eerste Percy op de markt)
   Audio-wc Q&A 06:43
   tinyurl.com/n67ktq
   It could be a product from - actually and English company that conducts the trial in America. The company's called Ark Therapeutics. And the
   product is called Trinam. It is for, basically, vascular repair after surgery. The product is Phase III and your guess is as good as mine when it
   comes out of Phase III.
   hugin.info/132631/R/1342823/321550.pdf
   
   I'm curious about the PER.C6 cell. There was a lot of controversy last year when you achieved very high yields.
   And I think some of your competitors were arguing that the main challenge is not to produce very high yields, but more the downstream prices
   (inaudible) whatever you have in those deals --.
   LEON KRUIMER - CFO
   Right.
   Unidentified Speaker
   -- if you can comment on what you view that as. And what they're getting wrong --?
   LEON KRUIMER - CFO
   Well, I think -- not actually wrong; I think that downstream processing is a challenge where you go from 100% what you produce to significantly
   lower amounts that you have of pure product, pure protein or antibody after you do the downstream processing.
   The question is, what was the curve from downstream processing? As long as the percentage that you will have left at the end of the day is the
   same - right, when your yield is very high, your production, 100% so to speak, will be higher than otherwise. And as accordingly, when you do
   the same amount of effectiveness in downstream processing, you will have more product in the end. So, we think that the yield on your primary
   production of the protein is extremely important because it will determine the amount of product that you have left after downstream processing.
   Unidentified Speaker
   Has any product produced in the PER.C6 cell line already been approved?
   LEON KRUIMER - CFO
   No. No.
   Unidentified Speaker
   If not, what's the --?
   LEON KRUIMER - CFO
   It's all in clinical trials.
   Unidentified Speaker
   Are there any specific safety concerns with the cell line in terms of being carcinogenic or --?
   LEON KRUIMER - CFO
   No. None. And I think in previous years, starting in 19 -- starting in 2000, we worked intensively with Merck, North America Merck, in order to
   come up with a biologics master file and address any safety concerns that the FDA would have, which allowed Merck to use PER.C6 as a
   production system in their HIV trials. And those trials were suddenly aborted because the product -- there were product issues, but not with the
   way that the vaccine was actually produced.
   So I think safety concerns have never been an issue, although we have to prove that it was very safe, but they are certainly not an issue today in
   the use and use (inaudible).
   There was a question over there.
   Unidentified Audience Member
   The FDA, so far, has been pretty reluctant on improving new adjuvant (inaudible) before it can happen. Does the model (inaudible) PER.C6,
   both (inaudible-microphone inaccessible).
   LEON KRUIMER - CFO
   The -- just to repeat it for the microphone. The question was that the FDA has been reluctant to approve new adjuvants, so how likely is it that
   PER.C6 would produce something, which needs an adjuvant? Or --?
   Unidentified Audience Member
   No, no, no, no. No which needs an adjuvant -- there is (inaudible-microphone inaccessible)
   LEON KRUIMER - CFO
   Right.
   Unidentified Audience Member
   And does that prevent its approval of the (inaudible)? I'm wondering, will it be -- (inaudible-microphone inaccessible)?
   LEON KRUIMER - CFO
   Well, the -- what we do in terms of making a vaccine is basically growing the virus on a cell-based production system. Right? That is somewhat
   apart from the fact whether that vaccine -- that raw material for the vaccine [CAP] needs to be adjuvated. So far a number of the recombinant
   vaccines, because they're live vaccines, are powerful enough not to be adjuvated. Virtually the products we have in our pipeline are not adjuvated.
   Maybe I understand it wrong, but --.
   Unidentified Audience Member
   Yes. I'm not talking about the latent or potential (inaudible-microphone inaccessible) adjuvant.
   LEON KRUIMER - CFO
   Right.
   Unidentified Audience Member
   I'm just talking about --.
   LEON KRUIMER - CFO
   Adjuvants period?
   Unidentified Audience Member
   How likely is it that we will see (inaudible) to approval with (inaudible-microphone inaccessible) in PER.C6 as a whole?
   LEON KRUIMER - CFO
   Well, I -- all I can say is that for the studies that we do, and as far as they're with the FDA, we agree to clinical endpoints and once that is agreed,
   the study -- maybe we need to talk about (inaudible) with the adjuvant. Adjuvant is something that's particularly controversial at certain times.
   But --
   Unidentified Speaker
   I don't think you're referring to (inaudible) at all -- I think it's more of a question -- yes?
   LEON KRUIMER - CFO
   Right.
   Unidentified Audience Member
   Okay. Fine.
   
10. flosz 5 mei 2010 12:25

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    quote:

    wilb52 schreef:

    Over 5 jaar bij optellen , Dirk.
    
    Het Crucell sprookje = uit geblazen door ... met een grote fluit.
    

    Doe die rits maar snel dicht....
    
    Kost Nigel Parker de kop….
    
    London, UK, 5 May 2010: Ark Therapeutics Group plc ("Ark" or the "Company") today provides an update on the strategic review initiated on 9 March 2010.
    
    Following the announcement on 9 March 2010 the Company has conducted a strategic review of its extensive portfolio of assets, their potential and the alternative strategies to optimise shareholder value.
    
    As previously disclosed, Ark has also entered into discussions with a number of parties regarding the potential sale of the Company. The Company has also received a number of approaches from parties expressing interest in discrete parts of the business.
    
    The strategic review of Ark's portfolio of assets has confirmed to the Board that there is significant value which can be created for shareholders, a conclusion which is further validated by the approaches from third parties relating to discrete parts of the business.
    
    The Board believes, furthermore, that the approaches received to date for a sale of the Company do not adequately reflect the value of the Company's assets. Until such time as discussions with the companies which have made approaches are formally terminated, however, the Company remains in an offer period for the purposes of the Takeover Code.
    
    The Board has concluded that shareholders' interests are best served by a change of strategy to one of selective partnering of programmes together with a plan to monetise certain assets. A number of events to validate the value of the Company are expected to be concluded in the next 12 months.
    
    The Board will continue discussions with those parties that have expressed an interest in discrete parts of the business as the Board believes that the change in strategy and these approaches have the potential to create superior near-term value for shareholders. This should also extend the cash runway beyond H2 2011 and provide the Company with more time to realise the value of its pipeline.
    
    Ark will seek a partner to complete the clinical development for Cerepro® now that all other aspects including the adenoviral platform are cleared for approval and will also minimise expenditure on Trinam® by modifying the existing trial to a Phase IIb and then seeking a partner for a final Phase III trial. Ark believes that the regulatory achievement with the adenoviral platform will also enable the Company to validate its early stage programmes more rapidly through partnering deals.
    
    In re-focusing the business for the next stage of its development, the Board has agreed with Nigel Parker that, after twelve years of leadership, he will step down from the Board and as CEO with immediate effect. Nigel has played a key role in the Company's progress and the Board wishes to extend its thanks to him for driving and steering Ark from an IP-based start-up business to be the first biotech company in the world to achieve an approvable gene-therapy platform. His knowledge and experience will remain available to Ark as he will continue as a consultant to the Company.
    
    Martyn Williams, currently CFO, has accepted the Board's invitation to take on the role of CEO with immediate effect. Martyn has been CFO since 1998 and has an intimate knowledge of all the Group's assets. The Board is confident that he has all the skills needed to implement the change of strategy.
    tinyurl.com/2ufebnh
    
11. [verwijderd] 5 mei 2010 14:04

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    Ik dacht dat ze bij Crucell nooit uitspraken deden (mochten doen) over voortgang van PerC6 producten bij derden?
    
    Dirk
12. [verwijderd] 5 mei 2010 14:18

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    quote:

    Dirk R. Wijnen schreef:

    Ik dacht dat ze bij Crucell nooit uitspraken deden (mochten doen) over voortgang van PerC6 producten bij derden?
    
    Dirk
    

    Aangepaste regelgeving noem ik dat.
    
13. flosz 14 juli 2010 08:45

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    Yesterday's news:
    
    A number of companies have completed or are in the process of completing due diligence on the Group's Woundcare business and negotiations are now in progress with a number of those companies. A further announcement on this will be made as soon as possible.
    
    Optimisation of the manufacturing facility's use and value is to be achieved through increasing the scale of contract manufacturing capacity and by entering into more formal collaborative partnerships. Detailed discussions with selected companies on a more strategic partnership are in progress and a growing number of companies are now in discussions for manufacturing services.
    
    ARK Trinam®(PER.C6 inside)
    Recruitment of patients into this trial is proving very difficult, due in part to a total focus in the Company on Cerepro® in the first quarter of 2010. A series of intensive remedial actions have been undertaken, leading to a recent increase in patients entering screening. Management is working closely with all the investigators to accelerate recruitment. In addition, one experienced clinical centre in a second country will be opened to accelerate the trial recruitment in parallel to the US centres.
    tinyurl.com/27xj5u3
    
14. flosz 13 augustus 2010 21:08

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    13 August 2010
    
    
    ARK THERAPEUTICS GROUP PLC (the "Company")
    
    POSTPONEMENT OF EXTRAORDINARY GENERAL MEETING ("EGM")
    
    In light of representations made to the Company by a number of shareholders, in part prompted by unavailability over the summer holiday season, the Board has taken the decision to reschedule the EGM from 11.00 a.m. on 19 August 2010 to 12 noon on 6 September 2010. The location of the EGM will not change.
    
    This will, in addition, allow the Board to convene and consider in detail the next steps in the implementation of its strategy, informed by its discussions with Iain Ross who has spent the recent weeks working alongside management undertaking a wholesale review of the Group's business and operations. The Board wishes to inform shareholders of the outcome of those deliberations in advance of the EGM and will, therefore, provide a further update as part of its half-yearly report, which is scheduled to be released on 25 August.
    
    In accordance with the Articles, the Board shall provide details of the postponed EGM in two UK national newspapers.
    tinyurl.com/2fsyulp
    
15. [verwijderd] 9 september 2010 10:33

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    uit :
    investors.arktherapeutics.com/servlet...
    
    Koers doet in ieder geval weer iets.
    
    ...
    Whilst over the last few months the Company has made progress with the development of Trinam®, the Board has concluded that a partner or licensee should be sought as the cost of development, the internal resource requirement and the clinical risk/reward ratio in this clinical setting is no longer appropriate for a Company of Ark's size. In addition the Company will continue its efforts to out-license Cerepro®. It should be noted, however, that future cash flow requirements for the re-shaped Company do not rely on any upside from either of these products.
    
    ...
    he directors believe the Company will have sufficient funds to support the business into 2013 by which time some significant value inflection points will have been established.
16. [verwijderd] 9 september 2010 11:26

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    Lage beurswaardering van Crucell blijft raadsel aldus AddValueFund. www.beurstweet.nl/amx-fondsen/crucell/
17. flosz 18 november 2010 19:22

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    Ark Therapeutics Group plc
    
    Interim Management Statement
    
    11 November 2010 - Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its interim management statement for the period from 1 July 2010 to date.
    
    Highlights
    
    •Major business restructuring and strategic repositioning announced 9 September
    
    •Interest in Ark's novel Neuropilin-1 programme from a number of pharma companies confirmed; discussions ongoing
    
    •Late-stage discussions continue for sale of Woundcare business, completion anticipated early 2011
    
    •Significant interest in Ark's manufacturing capabilities, detailed discussions with a number of parties have commenced
    
    •Cost reduction initiatives implemented; cash expected to last into 2013
    
    Major Business restructuring
    
    In September the Company announced a strategic restructuring of the business in which it would seek to generate value through capitalising on its core strengths in exploiting its approvable adenovirus platform and progressing its late-stage preclinical/early clinical product pipeline as well as realising the important commercial potential of its biologics manufacturing capabilities. In so doing Ark also announced it would seek partners to fund the further development of its later stage programmes, Cerepro® and Trinam®. AS A RESULT, THE COMPANY HAS NOW TAKEN THE STEPS TO SUSPEND THE TRINAM® PHASE IIB STUDY. IN ADDITION, ARK HAS THIS WEEK AMICABLY SETTLED THE FINNISH ARBITRATION PROCEEDINGS INITIATED BY AUSTRALIAN COMPANY VEGENICS LTD IN RELATION TO THE USE OF THE VEGF-D GENE IN TRINAM®. Also in September, Mr Iain Ross was appointed as Chairman to work with Martyn Williams, CEO, on implementing the new strategy. Mr Ross brings a wealth of experience to Ark, having held a number of senior positions in the biotechnology sector, including the manufacturing of biologics. An update on the status of the early stage product pipeline and of the exploitation of the manufacturing capability is provided below.
    
    Key Programmes
    
    •Neuropilin-1 - as announced in H1 this year, in-vivo results have shown Ark's small molecule antagonists to the Neuropilin-1 receptor significantly reduce tumour growth in a cancer model. Efforts are currently concentrated on optimising the molecule prior to beginning a formal partnering process. Early interest from big pharma companies has resulted in discussions beginning with potential partners interested in increasing the investment in this promising programme.
    
    •Foetal Growth Restriction (FGR) - further proof of principle pre-clinical studies in preparation for definitive toxicology have progressed well in the period and the Company expects to issue an update on this programme later this month.
    
    •VEGF-D programmes in refractory angina and peripheral vascular disease - the early clinical studies in collaboration with the AI Virtanen Institute are ongoing in Finland with interim results in both studies expected in mid-2011.
    
    Manufacturing
    
    The Group's world leading cGMP Biosafety level 2 certified manufacturing facility in Finland continues to generate interest from potential partners and discussions with a number of parties are underway. Continuing success in developing commercial-scale processes has prompted interest in Ark's capabilities from other companies.
    
    Woundcare
    
    Late stage discussions are taking place with a number of parties over the sale of the woundcare business and the Company expects to have completed the disposal by early 2011. Despite the uncertainty over the future ownership of this business, sales have continued to grow strongly and the woundcare business has been cash generative in the period since July.
    
    Cash
    
    We reported in our interim results announcement on 25 August 2010 that the Company had £14.1m in cash and money market investments at 30 June 2010. As a result of the cost saving initiatives implemented following the restructuring and taking into account the income generating plans already underway, including the sale of the Company's woundcare business, the directors believe the Company will have sufficient funds to support the business into 2013.
    
    Board
    
    As disclosed on 9 September 2010 Iain Ross was appointed Executive Chairman replacing Andrew Christie. Andrew has agreed to remain as a non-executive director for a limited time to ensure an orderly transition until a new independent non-executive director with product development experience is appointed.
    tinyurl.com/393esr9
    
    Generating Value from
    Core Strengths
    TRINAM: Risk in late stage development programmes too great for Ark
    investors.arktherapeutics.com/pdf/Gen...
    
18. flosz 18 november 2010 19:29

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    Q:What do you think will be the first product to go in front of the FDA using PER.C6
    A:It could be a product from - actually and English company that conducts the trial in America. The company's called Ark Therapeutics. And the
    product is called Trinam. It is for, basically, vascular repair after surgery. The product is Phase III and your guess is as good as mine when it
    comes out of Phase III.
    hugin.info/132631/R/1342823/321550.pdf
    Helaas!
19. [verwijderd] 18 november 2010 22:27

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    quote:

    flosz schreef:

    Q:What do you think will be the first product to go in front of the FDA using PER.C6
    A:It could be a product from - actually and English company that conducts the trial in America. The company's called Ark Therapeutics. And the
    product is called Trinam. It is for, basically, vascular repair after surgery. The product is Phase III and your guess is as good as mine when it
    comes out of Phase III.
    hugin.info/132631/R/1342823/321550.pdf
    Helaas!
    

    Ach ze hebben gewoon niet genoeg geld.
    
    Als de woundcare verkocht is weet ik wel een partij die de rest kan overnemen met een klein deel van haar cash in 2011 dus. van A naar C.
    Een ABC tje, waarna de verdere ontwikkeling sterk versneld kan worden.
20. flosz 30 november 2010 08:33

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    Positive results for Ark's pre-clinical product candidate EG013 in the treatment of foetal growth restriction
    tinyurl.com/2fj2xdw
    
    (Trinam® variant EG013)